MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a hole was found in the as lvp 20d 2ss cv tubing.The following information was provided by the initial reporter: "another set, same lot, had a hole.".

Manufacturer Narrative

It was reported that there was a hole in the iv tubing.Received from the customer is one used primary set model 2420-0007, lot 20033183.The set configuration was visually inspected as received for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a cut in the primary set tubing (p/n 660132), approximately 1 inch below the distal smartsite port.No other anomalies were observed throughout the set configuration.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the set allowing fluid to flow through the whole set by gravity.The set leaked from previously observed cut in the tubing.No other leaks were observed throughout the set.No further functional testing could be performed due to the leak from the tubing.A device history record for model 2420-0007, with lot number 20033183, was performed.The search showed that a total of (b)(4), units in 1 lot number were built on 10mar2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The customer¿s report of a hole in the tubing was confirmed.The root cause of the cut damage could not be determined.

Event Description

It was reported that a hole was found in the as lvp 20d 2ss cv tubing.The following information was provided by the initial reporter: "another set, same lot, had a hole.".

• Brand Name: AS LVP 20D 2SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10216198
• MDR Text Key: 198086659
• Report Number: 9616066-2020-01996
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/10/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20033183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other